-
Stroke and Vascular Neurology Jun 2024The incidence of vascular cognitive impairment (VCI) is high in patients suffering from ischaemic stroke or transient ischaemic attack (TIA) or with vascular risk...
Efficacy and safety of Ferrous iron on the prevention of Vascular cOgnitive impaiRment among patients with cerebral Infarction/TIA (FAVORITE): rationale and design of a multicentre randomised trial.
BACKGROUND
The incidence of vascular cognitive impairment (VCI) is high in patients suffering from ischaemic stroke or transient ischaemic attack (TIA) or with vascular risk factors. Effective prevention strategies for VCI remain limited. Anaemia or low haemoglobin was found as an independent risk factor for adverse outcomes after acute stroke. Anaemia or low haemoglobin was possibly associated with an increased risk of poststroke cognitive impairment. Whether supplement of ferrous iron to correct anaemia reduces the risk of VCI and improves adverse outcomes in patients with ischaemic cerebrovascular disease remains uncertain.
AIM
We aim to introduce the design and rationale of the safety and efficacy of Ferrous iron on the prevention of Vascular cOgnitive impaiRment in patients with cerebral Infarction or TIA (FAVORITE) trial.
DESIGN
FAVORITE is a randomised, placebo-controlled, double-blind, multicentre trial that compares supplement of ferrous iron with placebo for recent minor stroke/TIA patients complicated with mild anaemia or iron deficiency: Ferrous succinate sustained-release tablet 0.2 g (corresponding to 70 mg of elemental iron) once daily after or during breakfast for 12 weeks or placebo with much the same colour, smell and size as ferrous iron once daily during or after breakfast for 12 weeks. All paticipants will be followed within the next year.
STUDY OUTCOMES
The primary effective outcome is the incidence of VCI at 3 months after randomisation and the primary safety outcome includes any gastrointestinal adverse event during 3 months.
DISCUSSION
The FAVORITE trial will clarify whether supplement of ferrous iron to correct low haemoglobin reduces the risk of VCI in patients with recent ischaemic stroke or TIA complicated with mild anaemia or iron deficiency compared with placebo.
TRIAL REGISTRATION NUMBER
NCT03891277.
PubMed: 38789134
DOI: 10.1136/svn-2023-002644 -
Frontiers in Endocrinology 2024To evaluate the efficacy and safety of URLi (ultra rapid lispro insulin) compared to insulin lispro as bolus insulin with basal insulin using CGM in the individuals with... (Randomized Controlled Trial)
Randomized Controlled Trial
AIM
To evaluate the efficacy and safety of URLi (ultra rapid lispro insulin) compared to insulin lispro as bolus insulin with basal insulin using CGM in the individuals with type 2 diabetes(T2D) in China.
METHODS
This was a double-blind, randomized, parallel, prospective, phase 3 study. Subjects with uncontrolled T2D were recruited and randomized 1:2 into the insulin lispro and URLi groups. Subjects received a consistent basal insulin regimen during the study and self-administered insulin lispro or URLi before each meal throughout the treatment period. Subjects underwent a 3-day continuous glucose monitoring (CGM) at the baseline and endpoint respectively, and then CGM data were analyzed. The primary endpoint was to compare the difference in postprandial glucose (PPG) control using CGM between the two groups.
RESULTS
A total of 57 subjects with T2D completed the study. Our CGM data showed that postprandial glucose excursions after breakfast (BPPGE) in the URLi group was lower than that in the insulin lispro group (1.59 ± 1.57 mmol/L vs 2.51 ± 1.73 mmol/L, p = 0.046). 1-hour PPG was observed to decrease more in the URLi group than that in the insulin lispro group (-1.37 ± 3.28 mmol/L vs 0.24 ± 2.58 mmol/L, p = 0.047). 2-hour PPG was observed to decrease more in the URLi group than that in the insulin lispro group (-1.12 ± 4.00 mmol/L vs 1.22 ± 2.90 mmol/L, p = 0.021). The mean HbA1c level decreased by 1.1% in the URLi group and 0.99% in the insulin lispro group, with no treatment difference (p = 0.642). In the CGM profile, TBR was not significantly different between the two groups (p = 0.743). The weight gain also did not differ between the two groups (p = 0.303).
CONCLUSION
URLi can control breakfast PPG better than insulin lispro in adults with T2D in China, while it is non-inferior in improving HbA1c. The incidence of hypoglycemic and weight gain were similar between the two groups.
Topics: Humans; Diabetes Mellitus, Type 2; Insulin Lispro; Male; Female; Middle Aged; Postprandial Period; Blood Glucose; China; Double-Blind Method; Hypoglycemic Agents; Blood Glucose Self-Monitoring; Prospective Studies; Glycemic Control; Adult; Aged; Glycated Hemoglobin; Drug Therapy, Combination
PubMed: 38774225
DOI: 10.3389/fendo.2024.1364585 -
Journal of Medical Internet Research May 2024A plethora of weight management apps are available, but many individuals, especially those living with overweight and obesity, still struggle to achieve adequate weight...
BACKGROUND
A plethora of weight management apps are available, but many individuals, especially those living with overweight and obesity, still struggle to achieve adequate weight loss. An emerging area in weight management is the support for one's self-regulation over momentary eating impulses.
OBJECTIVE
This study aims to examine the feasibility and effectiveness of a novel artificial intelligence-assisted weight management app in improving eating behaviors in a Southeast Asian cohort.
METHODS
A single-group pretest-posttest study was conducted. Participants completed the 1-week run-in period of a 12-week app-based weight management program called the Eating Trigger-Response Inhibition Program (eTRIP). This self-monitoring system was built upon 3 main components, namely, (1) chatbot-based check-ins on eating lapse triggers, (2) food-based computer vision image recognition (system built based on local food items), and (3) automated time-based nudges and meal stopwatch. At every mealtime, participants were prompted to take a picture of their food items, which were identified by a computer vision image recognition technology, thereby triggering a set of chatbot-initiated questions on eating triggers such as who the users were eating with. Paired 2-sided t tests were used to compare the differences in the psychobehavioral constructs before and after the 7-day program, including overeating habits, snacking habits, consideration of future consequences, self-regulation of eating behaviors, anxiety, depression, and physical activity. Qualitative feedback were analyzed by content analysis according to 4 steps, namely, decontextualization, recontextualization, categorization, and compilation.
RESULTS
The mean age, self-reported BMI, and waist circumference of the participants were 31.25 (SD 9.98) years, 28.86 (SD 7.02) kg/m, and 92.60 (SD 18.24) cm, respectively. There were significant improvements in all the 7 psychobehavioral constructs, except for anxiety. After adjusting for multiple comparisons, statistically significant improvements were found for overeating habits (mean -0.32, SD 1.16; P<.001), snacking habits (mean -0.22, SD 1.12; P<.002), self-regulation of eating behavior (mean 0.08, SD 0.49; P=.007), depression (mean -0.12, SD 0.74; P=.007), and physical activity (mean 1288.60, SD 3055.20 metabolic equivalent task-min/day; P<.001). Forty-one participants reported skipping at least 1 meal (ie, breakfast, lunch, or dinner), summing to 578 (67.1%) of the 862 meals skipped. Of the 230 participants, 80 (34.8%) provided textual feedback that indicated satisfactory user experience with eTRIP. Four themes emerged, namely, (1) becoming more mindful of self-monitoring, (2) personalized reminders with prompts and chatbot, (3) food logging with image recognition, and (4) engaging with a simple, easy, and appealing user interface. The attrition rate was 8.4% (21/251).
CONCLUSIONS
eTRIP is a feasible and effective weight management program to be tested in a larger population for its effectiveness and sustainability as a personalized weight management program for people with overweight and obesity.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04833803; https://classic.clinicaltrials.gov/ct2/show/NCT04833803.
Topics: Humans; Feeding Behavior; Artificial Intelligence; Adult; Female; Male; Mobile Applications; Obesity; Middle Aged
PubMed: 38713909
DOI: 10.2196/46036 -
Journal of the Academy of Nutrition and... Apr 2024Limited data exist examining whether timing and/or duration of eating behaviors throughout the day affect sleep health.
BACKGROUND
Limited data exist examining whether timing and/or duration of eating behaviors throughout the day affect sleep health.
OBJECTIVE
The aim of this study was to identify the relationship between eating behaviors and sleep in young adults without chronic diseases or conditions.
DESIGN
This was a cross-sectional study using 7 days of baseline data from a randomized crossover trial.
PARTICIPANTS/SETTING
Participants included 52 young adults. The study took place in West Lafayette, Indiana, between April 2017 and May 2018.
MAIN OUTCOME MEASURES
Timing and duration of eating were assessed via 3 nonconsecutive, 24-hour dietary recalls. Bedtime, wake time, total sleep time, sleep latency, sleep efficiency, and wake after sleep onset were measured over 7 days via wrist actigraphy and sleep diaries.
STATISTICAL ANALYSES PERFORMED
Two-way analyses of variance were applied to assess group differences based on timing of consumption (early vs late eating) and duration of eating (long: >13 hours, short: <11 hours, or standard: 11-13 hours) with post-hoc pairwise comparisons.
RESULTS
Main effects of timing of consumption, but not duration of eating, were detected for wake time, bedtime, and sleep efficiency (all, P < .05). Specifically, participants with later eating patterns that included breakfast skipping had later wake times and later bedtimes than those with earlier eating patterns. In addition, those who had later eating patterns that included breakfast skipping and nighttime eating experienced lower sleep efficiency (mean [SE], 77.0% [2.3%]) vs those who consumed breakfast and no nighttime eating (mean [SE], 84.6% [1.4%]; P < .001) and those who skipped breakfast but had no nighttime eating (mean [SE], 84.2% [2.5]; P < .05). Those who consumed breakfast but also had nighttime eating had a mean (SE) sleep efficiency of 82.4% (1.4%) (P = .09).
CONCLUSIONS
The timing of eating was associated with sleep-wake onset and sleep efficiency. This study provides the preliminary characterization of eating behaviors relative to sleep-wake cycles and highlights the need for experimental studies to understand whether manipulating the timing of eating occasions to better align with sleep-wake cycles could improve sleep health.
PubMed: 38697355
DOI: 10.1016/j.jand.2024.04.016 -
Metabolism Open Jun 2024To assess the differences in glucose readings between the continuous glucose monitoring calibration-free interstitial sensors versus capillary blood glucose monitoring...
Differences in glucose readings between the continuous glucose monitoring calibration free interstitial sensors versus capillary blood glucose monitoring by glucometer: An analysis of two cases.
AIM
To assess the differences in glucose readings between the continuous glucose monitoring calibration-free interstitial sensors versus capillary blood glucose monitoring by glucometer.
STUDY DESIGN
Two healthy non-pregnant volunteers participated in the study, and wore simultaneously both the calibration-free Freestyle Libre and the Dexcom G6 sensor. Glucose values were recorded before and after meals during breakfast, lunch, and dinner on three separate days by either scanning the Freestyle Libre CGM sensor with a smartphone, or obtaining glucose readings real-time through the Dexcom G6 CLARITY mobile application. Blood glucose values were recorded using the Accu-Chek Active glucose meter. The Wilcoxon signed-rank test was used for paired non-parametric data to compare glucose readings between groups.
RESULTS
The average glucose values obtained from the Dexcom G6 CGM consistently registered higher (6.54 ± 0.80 mmol/L) and those from the Freestyle Libre (5.49 ± 0.65 mmol/L) consistently lower, from the glucometer (6.17 ± 0.55 mmol/L), with p-value <0.05 between groups. In the three-way comparison, the Dexcom G6 CGM sensor yielded the highest values, followed by the glucose meter, and finally the Freestyle Libre CGM sensor.
CONCLUSION
Both CGM systems exhibited discrepancies from blood glucose (BG) measurements, and variations were observed among the different CGM systems themselves.
PubMed: 38690155
DOI: 10.1016/j.metop.2024.100282 -
Cureus Mar 2024In the development and progression of type 2 diabetes mellitus, β-cell dysfunction occurs after insulin resistance. Despite poor glycaemic control, there is a practice...
BACKGROUND
In the development and progression of type 2 diabetes mellitus, β-cell dysfunction occurs after insulin resistance. Despite poor glycaemic control, there is a practice of increasing the dose of oral anti-diabetics or adding more drugs to the regimen due to the common perception that low endogenous insulin secretion is related to type 1 diabetes mellitus only and patient's poor compliance to injectables. Keeping this perspective in mind, this study was conducted to assess the prevalence of beta cell dysfunction by low serum C-peptide levels and its correlation with poor glycaemic control.
MATERIALS AND METHODS
A total of 134 patients with type 2 diabetes mellitus for more than 10 years on oral anti-diabetic drugs fulfilling our eligibility criteria were enrolled in our study. Blood samples for fasting blood sugar and fasting C-peptide level were taken before breakfast and uptake of anti-diabetic drugs. Correlation analysis was performed to evaluate the relationship between fasting C-peptide and glycaemic control with respect to glycated haemoglobin (HbA1c).
RESULTS
Of the patients, 19.40% had insufficient beta cell reserve serum levels (C-peptide < 0.5 ng/ml), of which most of the patients (14/26 = 53.85%) had poor glycaemic control (HbA1c < 8.0%). Overall, there was a significant correlation between poor glycaemic control with respect to HbA1c and low serum C-peptide levels (p < 0.05). We found a significant association of beta cell dysfunction (low fasting C-peptide level) with the use of insulin secretagogue. The proportion of patients with C-peptide levels less than 0.5 ng/ml was lower in patients using sodium-glucose cotransporter-2 (SGLT-2) inhibitors as compared to insulin secretagogue.
CONCLUSION
SGLT-2 inhibitors should be preferred over other anti-diabetic drugs as an add-on to existing metformin therapy. Insulin requirement must be assessed in patients who have long-term type 2 diabetes mellitus.
PubMed: 38654804
DOI: 10.7759/cureus.56810 -
Journal of Functional Morphology and... Apr 2024Four weeks before competition in the 2023 Marathon des Sables, a 6-stage, ~250 km running event in the Sahara Desert, we examined the effects of a 7-day intake of New...
Effects of CurraNZ, a New Zealand Blackcurrant Extract during 1 Hour of Treadmill Running in Female and Male Marathon des Sables Athletes in Hot Conditions: Two Case Studies.
Four weeks before competition in the 2023 Marathon des Sables, a 6-stage, ~250 km running event in the Sahara Desert, we examined the effects of a 7-day intake of New Zealand blackcurrant extract (210 mg anthocyanins per day) on 1 h treadmill running-induced physiological and metabolic responses in the heat (~34 °C, relative humidity: ~30%) in non-acclimatized amateur female and male athletes (age: 23, 38 yrs, BMI: 24.2, 28.4 kg·m, body fat%: 29.2, 18.8%, V˙O: 50.1, 52.1 mL·kg·min). During the 1 h run at 50%V˙O (speed female: 7.3, male: 7.5 km·h), indirect calorimetry was used, and heart rate was recorded at 15 min intervals with core temperature monitoring (0.05 Hz). The 1 h runs took place 3 h after a light breakfast and 2 h after intake of the final dose of New Zealand blackcurrant extract with water allowed ad libitum during the run. The New Zealand blackcurrant extract had no effects on the female athlete. The respiratory exchange ratio (RER) of the female athlete in the non-supplement control condition was 0.77 ± 0.01, indicating an existing ~77% contribution of fat oxidation to the energy requirements. In the male athlete, during 1 h of running, fat oxidation was higher by 21% ( < 0.01), carbohydrate oxidation was 31% lower ( = 0.05), RER was 0.03 units lower ( = 0.04), and core temperature was 0.4 °C lower ( < 0.01) with no differences for heart rate, minute ventilation, oxygen uptake, and carbon dioxide production for the New Zealand blackcurrant condition compared to the non-supplement control condition. Seven-day intake of New Zealand blackcurrant extract (210 mg anthocyanins per day) provided beneficial physiological and metabolic responses during exertional heat stress by 1 h of indoor (~34 °C) treadmill running in a male Marathon des Sables athlete 4 weeks before competition. Future work is required to address whether New Zealand blackcurrant provides a nutritional ergogenic effect for Marathon des Sables athletes during long-duration running in the heat combined with personalized nutrition.
PubMed: 38651434
DOI: 10.3390/jfmk9020076 -
Clinical, Cosmetic and Investigational... 2024A double-blind, placebo-controlled, randomized, proof-of-concept trial aimed to evaluate the efficacy and safety of Verbasnol [ Libosch leaf-based extract (RGLE)] in...
PURPOSE
A double-blind, placebo-controlled, randomized, proof-of-concept trial aimed to evaluate the efficacy and safety of Verbasnol [ Libosch leaf-based extract (RGLE)] in females, with moderate to severe acne vulgaris.
PARTICIPANTS AND METHODS
Twenty-two females aged 18 to 35 years having moderate to severe acne with Global Acne Grading System (GAGS) scores of 19 to 38 were included in the study and were randomized in a 1:1 ratio to receive either one capsule (100 mg/day) of RGLE or placebo orally after breakfast for 56 days. The primary outcome was a change in acne severity measured by the GAGS compared to the placebo on day 56. The secondary outcomes were changes in the number of inflammatory acne lesions, facial sebum secretion, quality of life, local pain and itching, skin wrinkle severity, and other skin characteristics, including radiance, luminosity, smoothness, texture, firmness, and hydration. Additionally, the percentage of responders and global tolerability and efficacy were evaluated.
RESULTS
The mean GAGS score was reduced by 21.72% and 14.20% on day 28 in RGLE (n=10) and placebo groups (n=12), respectively, which further reduced in both groups on day 56. The RGLE group reported better improvement in other skin characteristics on day 56. No safety or tolerability concerns were reported for the extract. RGLE reduced acne and improved the skin quality in females compared to placebo as early as 28 days of supplementation.
CONCLUSION
RGLE supplementation at a dose of 100 mg/day has provided a clinically relevant decrease in acne severity and improved the skin hydration and quality of life of the participants with acne after 56 days of dose administration.
PubMed: 38651075
DOI: 10.2147/CCID.S448928 -
BMC Public Health Apr 2024Currently, it is still largely unknown whether the proportion of calcium intake at breakfast and dinner is associated with cardiovascular disease (CVD) in the general...
Association of dietary calcium intake at dinner versus breakfast with cardiovascular disease in U.S. adults: the national health and nutrition examination survey, 2003-2018.
BACKGROUND
Currently, it is still largely unknown whether the proportion of calcium intake at breakfast and dinner is associated with cardiovascular disease (CVD) in the general population.
OBJECTIVES
The aim of this study was to evaluate the association of dietary calcium intake at dinner versus breakfast with CVD in a nationally representative sample of US adults.
METHODS
The study population consisted of 36,164 US adults (including 4,040 CVD cases) from the NHANES 2003 to 2018. According to the ratio of dietary calcium intake at dinner and breakfast (Δ = dinner/breakfast), 36,164 participants were divided into five groups. After adjustment for a series of confounder factors, logistic regression analyses were performed to examine the association between Δ and CVD. Dietary substitution models were used to explore the changes in CVD risk when a 5% dietary calcium intake at dinner was substituted with dietary calcium intake at breakfast.
RESULTS
Compared with participants in the lowest quintile, participants in the highest quintile were more likely to have CVD, with an adjusted OR of CVD of 1.16 (95% CI, 1.03 to 1.31). When the total calcium intake remained constant, replacing a 5% dietary calcium intake at dinner with dietary calcium intake at breakfast was associated with a 6% lower risk of CVD.
CONCLUSIONS
Compared to the lowest quintile of Δ, participants in the highest quintile of Δ were likely to experience CVD in the general population. It is necessary to scientifically allocate dietary calcium intake at breakfast and dinner.
Topics: Adult; Humans; Nutrition Surveys; Breakfast; Calcium, Dietary; Cardiovascular Diseases; Calcium; Meals
PubMed: 38641623
DOI: 10.1186/s12889-024-18587-7 -
Food Science & Nutrition Apr 2024Culinary herbs and spices are primarily known as flavor enhancers, research suggests that black pepper () and turmeric () have now been proven to prevent many...
The effect of turmeric and black pepper powder incorporated in breakfast on postprandial glycemia, appetite, palatability, and gastrointestinal well-being in normal-weight adults.
Culinary herbs and spices are primarily known as flavor enhancers, research suggests that black pepper () and turmeric () have now been proven to prevent many non-communicable chronic diseases such as diabetes. Bioactive components of black pepper and turmeric ameliorate glucose metabolism and appetite regulation. The present research was designed to investigate the impact of turmeric and black pepper on blood glycemia, gastrointestinal well-being, appetite, and palatability. In a randomized crossover study, four iso-caloric experimental meals each having 50 g of available carbohydrates were subjected to healthy human participants ( = 20). Turmeric and black pepper were incorporated in the breakfast meal, 1 g black pepper (BP), 1 g turmeric (TR), and combination of the (BP + TR) was added in the breakfast. Standard questionnaires were used to evaluate palatability, subjective appetite, and gastrointestinal well-being. Blood glycemia, subjective gastrointestinal well-being, and appetite were measured at 0, 30, 60, 120, and 180 min. Experimental meals BP and BP + TR resulted in lower blood glycemia ( < .05) significantly compared to control meal. A decrease in perceived eating ability and hunger, and an increase in satiety after BP + TR and BP meal was observed. No significant changes were observed after consuming test meals on gastrointestinal well-being. Compared to control and BP + TR meals, BP and TR meals had considerably lower palatability. Results showed that compared to the control intake of starchy meals supplemented with black pepper and turmeric reduced postprandial glycemia, hunger, and perceived eating ability without affecting gastrointestinal well-being.
PubMed: 38628217
DOI: 10.1002/fsn3.3965